Ultrafiltration Profiling and Outcomes Among Individuals on Maintenance Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 4
- 主要终点
- Change From Baseline in Percent Left Ventricular Global Longitudinal Strain (GLS)
研究概览
简要总结
The rate of fluid removal (ultrafiltration, UF) during hemodialysis (HD) may contribute to cardiovascular morbidity and mortality among individuals receiving maintenance HD. More rapid UF rates are associated with higher morbidity and mortality. Ultrafiltration profiling, the practice of varying UF rates to maximize fluid removal during periods of greatest hydration and plasma oncotic pressures, is one treatment modification that may reduce UF-related harm without necessitating reduction in interdialytic fluid intake or longer HD treatments. To date, UF profiling has not been adequately studied independent of sodium profiling.
This study investigates the comparative effect of UF profiling versus non-profiled conventional HD on select cardiovascular and patient-reported outcomes. Participants will complete two phases of UF profiling and two phases of conventional HD and will act as their own controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The study will be double-blinded in that participants will not be informed of the treatment paradigm. Investigators, including those performing transthoracic echocardiography (TTE) interpretation, will be blinded to treatment paradigm. Ultrasonographers performing intra-HD TTEs will be blinded to treatment paradigm.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •UF rate >10 mL/h/kg in >30% of treatments in a 30-day screening period (require ≥6 outpatient HD treatments in this period)
- •Age 18-85 years
- •Ability to converse comfortably in English or Spanish
- •Receipt of in-center maintenance HD at Carolina Dialysis clinics in Carrboro or Siler City, North Carolina
- •≥90 days on HD
- •Free of bloodstream infection during screening period
- •Willingness to undergo all study testing
- •Evidence of a signed and dated informed consent document
排除标准
- •Systolic BP unable to be measured by arm cuff
- •>1 hospitalization during screening period
- •Unstable angina per treating nephrologist
- •End-stage cirrhosis per treating nephrologist
- •New York Heart Association class IV heart failure per treating nephrologist
- •More than 4 times per week HD
- •Incarcerated
- •Anticipated kidney transplant within 6 months per treating nephrologist
- •Non-adherence to HD prescription (>2 unexplained absences during screening period)
- •Sodium profiling or UF profiling in standard HD prescription
- •Decisionally challenged, unable to provide informed consent
结局指标
主要结局
Change From Baseline in Percent Left Ventricular Global Longitudinal Strain (GLS)
时间窗: Weeks 3 and 7
Left ventricular GLS was measured with transthoracic echocardiography at baseline and at 30 minutes before HD treatment end during the 7th treatment in the first phase of each arm. Left ventricular GLS change was calculated as peak intradialytic stress GLS - baseline GLS (%). A lower change value reflects lesser cardiac strain. Median differences were estimated using Wilcoxon (Mann-Whitney) tests.
Occurrence of Intradialytic Hypotension (Intradialytic Hypotension Defined as Nadir Systolic BP <90 mmHg)
时间窗: Every study hemodialysis treatment, up to 36 treatments per participant over 15 weeks
Intradialytic blood pressure (BP) was measured with an upper extremity cuff in seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Intradialytic hypotension was defined as the presence of a nadir systolic BP \<90 mmHg. Odds ratios were estimated using a mixed model (repeated measures logistic regression model).
Pre- to Post-hemodialysis Treatment Change in Troponin T Level in ng/mL at Weeks 3, 7, 11, and 15, Using Mixed Model Analysis
时间窗: Weeks 3, 7, 11, and 15
Troponin T blood samples were collected at 4 study visits. Specifically, at the 7th hemodialysis treatment in each respective study phase (i.e., at week 3, 7, 11, and 15 study visits). Pre- to post-hemodialysis troponin T change was calculated as: post-dialysis troponin T - pre-dialysis troponin T (ng/mL). A lower change value reflects less cardiac strain. Based on the pre-specified protocol, the reported values represent change in troponin T between pre- and post-hemodialysis using mixed model (repeated measures logistic regression) analysis that considered all specified time-points (i.e., weeks 3, 7, 11, and 15).
Occurrence of a ≥10% Troponin T Percentage Rise From Pre- to Post-hemodialysis Treatment
时间窗: Weeks 3, 7, 11, and 15
Troponin T blood samples were collected before and after each participant's 7th hemodialysis treatment of each study phase (4 times during the study). Troponin T percentage change was calculated as \[(Post-HD troponin T - pre-HD troponin T) / pre-HD troponin T\] x100. Troponin T percentage rise was defined as a troponin T percentage change ≥10%. Odds ratios were estimated using a mixed model (repeated measures logistic regression model).
次要结局
- Occurrence of Patient-reported Clinically Important Nausea or Upset Stomach During Dialysis (Clinically Important Nausea or Upset Stomach Defined as Moderate, Severe, or Very Severe Nausea or Upset Stomach)(Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15)
- Occurrence of Patient-reported Clinically Important Dizziness or Lightheadedness During Dialysis (Clinically Important Dizziness or Lightheadedness Defined as Moderate, Severe, or Very Severe Dizziness or Lightheadedness)(Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15)
- Occurrence of Patient-reported Clinically Important Vomiting or Throwing up During Dialysis (Clinically Important Vomiting or Throwing up Defined as Moderate, Severe, or Very Severe Vomiting or Throwing up)(Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15)
- Occurrence of Patient-reported Clinically Important Racing Heart or Heart Palpitations During Dialysis (Clinically Important Racing Heart or Heart Palpitations Defined as Moderate, Severe, or Very Severe Racing Heart or Heart Palpitations)(Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15)
- Nadir Systolic Blood Pressure During Hemodialysis in mmHg(Every study hemodialysis treatment, up to 36 treatments per participant over 15 weeks)
- Occurrence of Patient-reported Clinically Important Thirst or Dry Mouth During Dialysis (Clinically Important Thirst or Dry Mouth Defined as Moderate, Severe, or Very Severe Thirst or Dry Mouth)(Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15)
- Occurrence of Patient-reported Clinically Important Headache During Dialysis (Clinically Important Headache Defined as Moderate, Severe, or Very Severe Headache)(Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15)
- Occurrence of Patient-reported Clinically Important Chest Pain During Dialysis (Clinically Important Chest Pain Defined as Moderate, Severe, or Very Severe Chest Pain)(Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15)
- Occurrence of Patient-reported Clinically Important Restless Legs During Dialysis (Clinically Important Restless Legs Defined as Moderate, Severe, or Very Severe Restless Legs)(Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15)
- Occurrence of Failed Target Weight Achievement (Failed Target Weight Achievement Defined as a Difference in Prescribed Target Weight and Post-dialysis Weight That is >1 kg or <-1 kg)(Every study hemodialysis treatment, up to 36 treatments per participant over 15 weeks)
- Occurrence of Patient-reported Clinically Important Cramping During Dialysis (Clinically Important Cramping Defined as Moderate, Severe, or Very Severe Cramping)(Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15)
- Occurrence of Patient-reported Clinically Important Shortness of Breath During Dialysis (Clinically Important Shortness of Breath Defined as Moderate, Severe, or Very Severe Shortness of Breath)(Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15)
- Occurrence of Patient-reported Clinically Important Itching During Dialysis (Clinically Important Itching Defined as Moderate, Severe, or Very Severe Itching)(Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15)
- Occurrence of Patient-reported Clinically Important Tingling or Feeling of Pins and Needles During Dialysis (Clinically Important Tingling or Feeling of Pins and Needles Defined as Moderate, Severe, or Very Severe Tingling or Feeling of Pins and Needles)(Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15)